Cleared Traditional

K903963 - KITS AND TRAYS FOR ONE TIME USE ONLY

K903963 is an FDA 510(k) clearance for KITS AND TRAYS FOR ONE TIME USE ONLY, manufactured by Apk Technology. The device is a Class 1 General & Plastic Surgery device with product code LRP cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K903963 · Apk Technology · General & Plastic Surgery device
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Jul 1991
Decision
335d
Days
Class 1
Risk

K903963 is an FDA 510(k) clearance for the KITS AND TRAYS FOR ONE TIME USE ONLY. Classified as Tray, Surgical (product code LRP), Class I - General Controls.

Submitted by Apk Technology (Israel, IL). The FDA issued a Cleared decision on July 29, 1991 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Apk Technology devices

FDA 510(k) Submission Details - K903963

510(k) Number K903963 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 28, 1990
Decision Date July 29, 1991
Days to Decision 335 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 115d · This submission: 335d
Pathway characteristics
Predicate-based equivalence.

LRP Device Classification - Class 1, General Controls

Product Code LRP Tray, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LRP Tray, Surgical

All 11
Devices cleared under the same product code (LRP) and FDA review panel - the closest regulatory comparables to K903963.
EYE TRAY
K940239 · Cush Medical Products · Jun 1994
GENERAL SURGERY TRAY
K940444 · Cush Medical Products · Mar 1994
EYE TRAY
K912105 · Medical Device Inspection Co., Inc. · Aug 1991
SITE STERILIZATION TRAYS FOR OPHTHALMIC USE
K883098 · Site Microsurgical Systems, Inc. · Aug 1988
KOI(TM) INSTRUMENT TRAYS
K881095 · CooperVision, Inc. · Apr 1988
SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY
K874665 · Precision Dynamics Corp. · Jan 1988